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Cesarean Delivery Affecting NewbornNewbornMicrobiomeWeight lossChildren's healthBiologicalPhase 1, Phase 2

What this study is

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

What's being tested

  • Vaginal Seeding

    Intervention · BIOLOGICAL

    A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.

  • No Vaginal Seeding

    Intervention · OTHER

    A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Study details

Official title
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
Cesarean Delivery Affecting Newborn · Obesity, Childhood · Intestinal Microbiome · Microbiota · Host Microbial Interactions · Gastrointestinal Microbiome
Enrolling
600 people
Starts
2018-07-01
Est. completion
2029-04
Design
Triple-blind, randomized, parallel groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗